NCT06016972

Qlaris Phase 2 Study of QLS-111 in POAG And/or OHT Patients

A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 Vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Qlaris Bio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Qlaris' Phase 2 clinical trial investigating the safety, tolerability, and ocular hypotensive efficacy of QLS-111 in primary open-angle glaucoma (POAG) or ocular hypertension patients.

Detailed description

A randomized, active- and vehicle-controlled, multi-site, double-masked study to evaluate the safety and tolerability of QLS-111 versus vehicle in subjects with primary open-angle glaucoma or ocular hypertension. Primary objective is to evaluate the ocular and systemic safety and tolerability of 3 concentrations of QLS-111 compared to vehicle control. Secondary objective is to evaluate the ocular hypotensive efficacy of 3 concentrations of QLS-111 with once daily morning (QAM), once daily evening (QPM), and twice daily (BID) dosing versus vehicle with QAM, QPM, and BID dosing.

Conditions

• Primary Open Angle Glaucoma (POAG)
• Primary Open Angle Glaucoma of Both Eyes
• Primary Open-Angle Glaucoma, Unspecified Eye
• Ocular Hypertension (OHT)

Interventions

Type	Name	Description
DRUG	Experimental: QLS-111 ophthalmic solution, (0.015%)	QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
DRUG	Experimental: QLS-111 ophthalmic solution, (0.03%)	QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
DRUG	Experimental: QLS-111 ophthalmic solution, (0.075%)	QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
OTHER	QLS-111 ophthalmic vehicle solution	Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.

Timeline

• Start date: 2024-03-05
• Primary completion: 2024-08-20
• Completion: 2024-08-20
• First posted: 2023-08-30
• Last updated: 2025-01-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study